TY - JOUR
T1 - Tranexamic acid to prevent operation in chronic subdural haematoma (TORCH)
T2 - study protocol for a randomised placebo-controlled clinical trial
AU - Immenga, S.
AU - Lodewijkx, R.
AU - Roos, Y. B.W.E.M.
AU - Middeldorp, S.
AU - Majoie, C. B.L.M.
AU - Willems, H. C.
AU - Vandertop, W. P.
AU - Verbaan, D.
N1 - Funding Information: The trial is funded by a grant obtained from ZonMW, the Netherlands Organisation for Health Research and Development. The study is registered under project number 848081003. After the authors applied for the ZonMW grant, minor modifications were made to form the final study protocol. ZonMW approved this final study protocol. ZonMW also approved a Data Management Plan that describes the methods of data collection, data storage and data availability after completion of the trial. ZonMW has no role in the interpretation of the results of the study. Publisher Copyright: © 2021, The Author(s).
PY - 2022/12/1
Y1 - 2022/12/1
N2 - Background: Chronic subdural haematoma (cSDH) occurs mainly in the elderly. Surgical evacuation is effective, but in these old, often frail, patients with multi-comorbidity, surgery carries significant risks for future cognitive functioning and loss of independency. Therefore, a growing interest is noted for a non-surgical treatment with medication such as tranexamic acid (TXA). In five small retrospective series, this antifibrinolytic drug showed a beneficial effect on the spontaneous resolution of the haematoma, and with that, the necessity for surgery. Methods: For this randomised, placebo-controlled clinical multicentre trial, all cSDH patients, over 50 years old with mild symptoms (Glasgow Coma Score (GCS) ≥ 14, modified National Institutes of Health Stroke Scale (mNIHSS) ≤ 4), a midline shift of ≤ 10 mm and in whom a primary conservative treatment is chosen, are eligible for study participation. After informed consent, 140 patients will be randomised to receive either TXA 500 mg or placebo two times daily for 28 days. The primary outcome is the necessity for surgery within 12 weeks; secondary outcomes are cSDH volume, neurological impairment (mNIHSS), falling incidents, cognitive functioning (Montreal Cognitive Assessment (MOCA)), performance in activities of daily living (Barthel and Lawton score), functional outcome (modified Rankin Scale (mRS)), quality of life (Short Form Health Survey (SF-36) and EuroQol 5-Dimension Health Survey (EQ-5D)), mortality and the use of care and health-related costs (Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ)) at 12 weeks and 6 months. Discussion: This phase III trial investigating the efficacy of TXA to prevent surgery for cSDH is the first in including patients using anticoagulants and mentally incompetent patients, since these comprise a significant part of the target population. Also, this study is one of the first to prospectively measure functional outcome and quality of life in cSDH patients. Final results of this study are expected in 2024. Trial registration: Dutch Trial Registry (Nederlands Trial Register) NL6584. Registered on 11 November 2017 ClinicalTrials.govNCT03582293. Registered on 11 July 2018 EU Clinical Trials Register 2017-004311-40. Registered on 29 March 2018
AB - Background: Chronic subdural haematoma (cSDH) occurs mainly in the elderly. Surgical evacuation is effective, but in these old, often frail, patients with multi-comorbidity, surgery carries significant risks for future cognitive functioning and loss of independency. Therefore, a growing interest is noted for a non-surgical treatment with medication such as tranexamic acid (TXA). In five small retrospective series, this antifibrinolytic drug showed a beneficial effect on the spontaneous resolution of the haematoma, and with that, the necessity for surgery. Methods: For this randomised, placebo-controlled clinical multicentre trial, all cSDH patients, over 50 years old with mild symptoms (Glasgow Coma Score (GCS) ≥ 14, modified National Institutes of Health Stroke Scale (mNIHSS) ≤ 4), a midline shift of ≤ 10 mm and in whom a primary conservative treatment is chosen, are eligible for study participation. After informed consent, 140 patients will be randomised to receive either TXA 500 mg or placebo two times daily for 28 days. The primary outcome is the necessity for surgery within 12 weeks; secondary outcomes are cSDH volume, neurological impairment (mNIHSS), falling incidents, cognitive functioning (Montreal Cognitive Assessment (MOCA)), performance in activities of daily living (Barthel and Lawton score), functional outcome (modified Rankin Scale (mRS)), quality of life (Short Form Health Survey (SF-36) and EuroQol 5-Dimension Health Survey (EQ-5D)), mortality and the use of care and health-related costs (Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ)) at 12 weeks and 6 months. Discussion: This phase III trial investigating the efficacy of TXA to prevent surgery for cSDH is the first in including patients using anticoagulants and mentally incompetent patients, since these comprise a significant part of the target population. Also, this study is one of the first to prospectively measure functional outcome and quality of life in cSDH patients. Final results of this study are expected in 2024. Trial registration: Dutch Trial Registry (Nederlands Trial Register) NL6584. Registered on 11 November 2017 ClinicalTrials.govNCT03582293. Registered on 11 July 2018 EU Clinical Trials Register 2017-004311-40. Registered on 29 March 2018
KW - Activities of daily living
KW - Antifibrinolytic agents
KW - Conservative treatment
KW - Haematoma, Subdural, Chronic
KW - Neurosurgery
KW - Quality of life
KW - Tranexamic acid
UR - http://www.scopus.com/inward/record.url?scp=85123069197&partnerID=8YFLogxK
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85123069197&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/35042560
U2 - https://doi.org/10.1186/s13063-021-05907-0
DO - https://doi.org/10.1186/s13063-021-05907-0
M3 - Article
C2 - 35042560
SN - 1745-6215
VL - 23
JO - Trials
JF - Trials
IS - 1
M1 - 56
ER -